Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2014 | Nov. 03, 2014 | |
Document And Entity Information [Abstract] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Sep-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Trading Symbol | 'OGEN | ' |
Entity Registrant Name | 'ORAGENICS INC | ' |
Entity Central Index Key | '0001174940 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Smaller Reporting Company | ' |
Entity Common Stock, Shares Outstanding | ' | 36,178,944 |
Balance_Sheets
Balance Sheets (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Current assets: | ' | ' |
Cash and cash equivalents | $11,764,923 | $16,276,510 |
Accounts receivable, net | 26,309 | 64,434 |
Inventory, net | 263,860 | 288,383 |
Prepaid expenses and other current assets | 221,637 | 175,242 |
Total current assets | 12,276,729 | 16,804,569 |
Property and equipment, net | 26,296 | 26,913 |
Total assets | 12,303,025 | 16,831,482 |
Current liabilities: | ' | ' |
Accounts payable and accrued expenses | 604,351 | 909,957 |
Short-term notes payable | 109,564 | 64,051 |
Deferred revenue | 25,592 | 18,839 |
Total current liabilities | 739,507 | 992,847 |
Shareholders' equity: | ' | ' |
Preferred stock, no par value; 20,000,000 shares authorized; none issued and outstanding | 0 | ' |
Common stock, $0.001 par value; 100,000,000 and 50,000,000 shares authorized as of September 30, 2014 and December 31, 2013, respectively; 36,178,944 and 35,993,944 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively | 36,179 | 35,994 |
Additional paid-in capital | 86,248,402 | 85,957,757 |
Accumulated deficit | -74,721,063 | -70,155,116 |
Total shareholders' equity | 11,563,518 | 15,838,635 |
Total liabilities and shareholders' equity | $12,303,025 | $16,831,482 |
Balance_Sheets_Parenthetical
Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Statement of Financial Position [Abstract] | ' | ' |
Preferred stock, par value | ' | ' |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 100,000,000 | 50,000,000 |
Common stock, shares issued | 36,178,944 | 35,993,944 |
Common stock, shares outstanding | 36,178,944 | 35,993,944 |
Statements_of_Operations_Unaud
Statements of Operations (Unaudited) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Income Statement [Abstract] | ' | ' | ' | ' |
Revenue, net | $201,010 | $253,374 | $719,422 | $597,449 |
Cost of sales | 73,711 | 113,384 | 279,076 | 263,990 |
Gross profit | 127,299 | 139,990 | 440,346 | 333,459 |
Operating expenses: | ' | ' | ' | ' |
Research and development | 597,034 | 6,907,250 | 2,516,826 | 8,289,614 |
Selling, general and administrative | 565,114 | 2,558,205 | 2,509,843 | 5,180,702 |
Total operating expenses | 1,162,148 | 9,465,455 | 5,026,669 | 13,470,316 |
Loss from operations | -1,034,849 | -9,325,465 | -4,586,323 | -13,136,857 |
Other income (expense): | ' | ' | ' | ' |
Interest income | 8,656 | 3,611 | 29,175 | 15,098 |
Interest expense | -1,305 | -1,546 | -2,856 | -3,339 |
Local business tax | -2,046 | -2,024 | -5,740 | -8,824 |
Other income (expense) | ' | ' | -203 | 144,503 |
Total other income (expense), net | 5,305 | 41 | 20,376 | 147,438 |
Loss before income taxes | -1,029,544 | -9,325,424 | -4,565,947 | -12,989,419 |
Income tax benefit | ' | ' | ' | ' |
Net loss | ($1,029,544) | ($9,325,424) | ($4,565,947) | ($12,989,419) |
Basic and diluted net loss per share | ($0.03) | ($0.34) | ($0.13) | ($0.47) |
Shares used to compute basic and diluted net loss per share | 36,178,944 | 27,515,372 | 36,145,043 | 27,496,676 |
Statements_of_Cash_Flows_Unaud
Statements of Cash Flows (Unaudited) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Cash flows from operating activities: | ' | ' |
Net loss | ($4,565,947) | ($12,989,419) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Technology access fee paid in common stock and convertible note payable to shareholder | ' | 6,000,000 |
Depreciation and amortization | 20,119 | 64,042 |
Loss on sale of property and equipment | 203 | ' |
Stock issued as compensation to non-employee directors | 102,500 | ' |
Stock-based compensation expense | 188,330 | 1,624,165 |
Write off of expired inventory | ' | -240,005 |
Changes in operating assets and liabilities: | ' | ' |
Accounts receivable, net | 38,125 | 10,917 |
Inventory, net | 24,523 | 140,865 |
Prepaid expenses and other current assets | 112,604 | 151,861 |
Accounts payable and accrued expenses | -305,606 | -280,353 |
Deferred revenue | 6,753 | -27,278 |
Net cash used in operating activities | -4,378,396 | -5,545,205 |
Cash flows from investing activities: | ' | ' |
Proceeds from sale of property and equipment | 424 | ' |
Purchase of property and equipment | -20,129 | -17,649 |
Net cash used in investing activities | -19,705 | -17,649 |
Cash flows from financing activities: | ' | ' |
Payments on short-term notes payable | -113,486 | -96,788 |
Net proceeds from issuance of common stock | ' | 3,939,800 |
Restricted cash released | ' | 61,763 |
Net cash (used in) provided by financing activities | -113,486 | 3,904,775 |
Net decrease in cash and cash equivalents | -4,511,587 | -1,658,079 |
Cash and cash equivalents at beginning of period | 16,276,510 | 9,925,967 |
Cash and cash equivalents at end of period | 11,764,923 | 8,267,888 |
Supplemental disclosure of cash flow information: | ' | ' |
Interest paid | 2,997 | 3,108 |
Non-cash investing and financing activities: | ' | ' |
Borrowings under short-term notes payable for prepaid expense | 158,999 | 157,031 |
Par value of common stock issued for cashless exercise of warrants | $135 | $106 |
Organization
Organization | 9 Months Ended | |
Sep. 30, 2014 | ||
Accounting Policies [Abstract] | ' | |
Organization | ' | |
1 | Organization | |
Oragenics, Inc. (formerly known as Oragen, Inc.) (the “Company” or “we”) was incorporated in November 1996; however, operating activity did not commence until 1999. The Company is focused on the discovery, development and commercialization of a variety of technologies associated with broad spectrum antibiotics, oral health, and other general health benefits. |
Basis_of_Presentation
Basis of Presentation | 9 Months Ended | |
Sep. 30, 2014 | ||
Accounting Policies [Abstract] | ' | |
Basis of Presentation | ' | |
2 | Basis of Presentation | |
The accompanying unaudited interim financial statements as of September 30, 2014 and December 31, 2013 (audited) and for the three and nine months ended September 30, 2014 and 2013 have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the accompanying financial statements include all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the financial condition, results of operations and cash flows for the periods presented. The results of operations for the interim period September 30, 2014 are not necessarily indicative of the results that may be expected for the year ending December 31, 2014 or any future period. | ||
These financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2013, which are included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2014. The Company has incurred recurring losses and negative cash flows from operations since inception. To date the Company has not generated significant revenues from operations. The Company generated revenues of $719,422, incurred a net loss of $4,565,947, and used cash of $4,378,396 in its operating activities during the nine months ended September 30, 2014. As of September 30, 2014, the Company had an accumulated deficit of $74,721,063. | ||
During 2012 and 2011, a significant source of debt and equity funding was provided to the Company by its largest shareholder, the Koski Family Limited Partnership (the “KFLP”). In addition, in 2013 and 2012 the Company raised $14,900,000 and $13,000,000 in gross proceeds through the private placement sale of its common stock. The Company expects to incur substantial expenditures to further develop each of its technologies. The Company believes the working capital at September 30, 2014 will be sufficient to meet the business objectives as presently structured through June 2015. | ||
The Company’s ability to continue operations after its current cash resources are exhausted depends on its ability to obtain additional financing or achieve profitable operations, as to which no assurances can be given. Cash requirements may vary materially from those now planned because of changes in the Company’s focus and direction of its research and development programs, competitive and technical advances, or other developments. Additional financing will be required to continue operations after the Company exhausts its current cash resources and to continue its long-term plans for clinical trials and new product development. There can be no assurance that any such financing can be realized by the Company, or if realized, what the terms thereof may be, or that any amount that the Company is able to raise will be adequate to support the Company’s working capital requirements until it achieves profitable operations. | ||
The Company intends to seek additional funding through sublicensing arrangements, joint venturing or partnering, sales of rights to technology, government grants and public or private financings. The Company’s future success depends on its ability to raise capital and ultimately generate revenue and attain profitability. The Company cannot be certain that additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of its common stock, and the Company’s current shareholders may experience dilution. If the Company is unable to obtain funds when needed or on acceptable terms, the Company may be required to curtail their current development programs, cut operating costs and forego future development and other opportunities. |
Significant_Accounting_Policie
Significant Accounting Policies | 9 Months Ended | |
Sep. 30, 2014 | ||
Accounting Policies [Abstract] | ' | |
Significant Accounting Policies | ' | |
3 | Significant Accounting Policies | |
Recently Issued Accounting Pronouncements | ||
In August 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40) Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern.” ASU 2014-15 provides guidance on management’s responsibility in evaluating whether there is substantial doubt about a company’s ability to continue as a going concern and about related footnote disclosures. For each reporting period, management will be required to evaluate whether there are conditions or events that raise substantial doubt about a company’s ability to continue as a going concern within one year from the date the financial statements are issued. Management will also be required to evaluate and disclose whether its plans alleviate that doubt. ASU 2014 – 15 is effective for the annual period ending after December 15, 2016, and for interim periods within annual periods ending after December 15, 2016. Earlier application is permitted. The Company is currently evaluating the requirements of ASU 2014-15 and has not yet determined its impact on the Company’s financial statements. | ||
In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2014-09, “Revenue from Contracts with Customers (Topic 606).” ASU 2014-09 completes the joint effort by the FASB and International Accounting Standards Board (IASB) to improve financial reporting by creating common revenue recognition guidance for U.S. GAAP and International Financial Reporting Standards (IFRS). ASU 2014-09 applies to all companies that enter into contracts with customers to transfer goods or services. ASU 2014-09 is effective for public entities for interim and annual reporting periods beginning after December 15, 2016. Early application is not permitted and entities have the choice to apply ASU 2014-09 either retrospectively to each reporting period presented or by recognizing the cumulative effect of applying ASU 2014-09 at the date of initial application and not adjusting comparative information. The Company is currently evaluating the requirements of ASU 2014-09 and has not yet determined its impact on the Company’s financial statements. | ||
In July 2013, the FASB issued new accounting guidance on the presentation of unrecognized tax benefits, Accounting Standards Update No. 2013-11, “Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists,” for fiscal years, and interim periods within those years, beginning after December 15, 2013 The new guidance requires an entity to present an unrecognized tax benefit, or a portion of an unrecognized tax benefit, as a reduction to a deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward, except as follows: to the extent a net operating loss carryforward, a similar tax loss, or a tax credit carryforward is not available at the reporting date under the tax law of the applicable jurisdiction to settle any additional income taxes that would result from the disallowance of a tax position or the tax law of the applicable jurisdiction does not require the entity to use, and the entity does not intend to use the deferred tax asset for such purpose, then the unrecognized tax benefit should be presented in the financial statements as a liability and should not be combined with deferred tax assets. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2013, with early adoption permitted. Accordingly, we adopted these presentation requirements during the first quarter of 2014. The adoption of this new guidance did not have a material impact on our financial statements or related disclosures. | ||
There are no other new accounting pronouncements issued or effective during the third quarter of 2014 that have had or are expected to have an impact on the Company’s financial statements. | ||
Use of Estimates | ||
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. The principal areas of estimation reflected in the financial statements are anticipated milestone payments, stock based compensation, valuation of warrants, income tax valuation allowance, inventory obsolescence reserve, sales returns and allowances and the allowance for doubtful accounts. | ||
Guaranteed Rights of Return | ||
The Company has granted guaranteed rights of return to two dental distributors. The Company defers recognition of revenue on these accounts until either the distributor provides notification to the Company that the product has been sold to the end consumer or the guaranteed right of return period expires. Once notification has been received and verified, the Company records revenue in that accounting period. The Company had $25,592 and $18,839 of revenue deferred under guaranteed rights of return arrangements included in deferred revenue in the balance sheets as of September 30, 2014 and December 31, 2013, respectively. | ||
Inventory | ||
Inventory is stated at the lower of cost or market. Cost, which includes material, labor and overhead, is determined on a first-in, first-out basis. On a quarterly basis, we analyze our inventory levels and reserve for inventory that is expected to expire prior to being sold, inventory that has a cost basis in excess of its expected net realizable value, inventory in excess of expected sales requirements, or inventory that fails to meet commercial sale specifications. Expired inventory is disposed of and the related costs are written off to the reserve for inventory obsolescence. The inventory reserve was approximately $41,200 and $31,500 as of September 30, 2014 and December 31, 2013, respectively. | ||
Stock-Based Payment Arrangements | ||
Generally, all forms of stock-based payments, including stock option grants, warrants, and restricted stock grants are measured at their fair value on the awards’ grant date typically using a Black-Scholes pricing model. Stock-based compensation awards issued to non-employees for services rendered are recorded at the fair value of the stock-based payment. The expense resulting from stock-based payments are recorded in research and development expense or selling, general and administrative expense in the statement of operations, depending on the nature of the services provided. Stock-based payment expense is recorded over the requisite service period in which the grantee provides services to us, to the extent the stock option grants, warrants, or restricted stock grants do not vest at the grant date they are subject to forfeiture. | ||
Stock-Based Compensation | ||
GAAP requires all share-based payments to employees, including grants of employee stock options, to be recognized in the financial statements based on their fair values as of the grant date. Stock-based compensation expense is recorded over the requisite service period in which the grantee provides services to us, to the extent the options do not vest at the grant date and are subject to forfeiture. For performance-based awards that do not include market-based conditions, we record share-based compensation expense only when the performance-based milestone is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether milestones are probable of achievement. | ||
For awards with market-based performance conditions, we recognize the grant-date fair value of the award over the derived service period regardless of whether the underlying performance condition is met. | ||
Warrants | ||
The Company used the Black Scholes Option Pricing Model in calculating the relative fair value of any warrants that are issued. | ||
Net Loss Per Share | ||
During all periods presented, the Company had securities outstanding that could potentially dilute basic earnings per share in the future, but were excluded from the computation of diluted net loss per share, as their effect would have been antidilutive. Because the Company reported a net loss for all periods presented, shares associated with the stock options and warrants are not included because they are antidilutive. Basic and diluted net loss per share amounts are the same for the periods presented. Net loss per share is computed using the weighted average number of shares of common stock outstanding. | ||
Revenue Recognition | ||
The Company recognizes revenues from the sales of product when title and risk of loss pass to the customer, which is generally when the product is shipped. Grant revenues are recognized as the reimbursable expenses are incurred over the life of the related grant. Grant revenues are deferred when reimbursable expenses have not been incurred. | ||
The Company records allowances for discounts and product returns at the time of sale as a reduction of revenues as such allowances can be reliably estimated based on historical experience or known trends. The Company maintains a return policy that allows customers to return product within a specified period of time prior to and subsequent to the expiration date of the product. The estimate of the provision for returns is analyzed quarterly and is based upon many factors, including industry data of product return rates, historical experience of actual returns, analysis of the level of inventory in the distribution channel, if any, and reorder rates. If the history or product returns changes, the reserve will be adjusted. While the Company believes that the reserves it has established are reasonable and appropriate based upon current facts and circumstances, applying different judgments to the same facts and circumstances would result in the estimated amounts for sales returns and chargebacks to vary. Because the ProBiora3 products have only had limited distribution, the Company could experience different circumstances in the future and these differences could be material. | ||
Concentrations | ||
The Company is dependent on key suppliers to provide probiotics, blending, warehousing and packaging of its EvoraPlus, EvoraKids, EvoraPro, and Teddy’s Pride products. The Company had four key suppliers during the three and nine months ended September 30, 2014 and 2013. The majority of the Company’s cost of sales are from these key suppliers during the three and nine months ended September 30, 2014 and 2013. Accounts payable and accrued expenses for these vendors totaled approximately $90,504 and $146,284 as of September 30, 2014 and December 31, 2013, respectively. | ||
Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains cash accounts in commercial banks, which may, at times, exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk on cash and cash equivalents. As of September 30, 2014, the uninsured portion of this balance was $11,514,923. As of December 31, 2013, the uninsured portion of this balance was $16,026,510. |
Stockbased_Compensation
Stock-based Compensation | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | ||||||||||||||||
Stock-based Compensation | ' | ||||||||||||||||
4 | Stock-based Compensation | ||||||||||||||||
The Company recognized stock-based compensation on all employee and non-employee awards as follows: | |||||||||||||||||
Three Months Ended | Three Months Ended | Nine Months Ended | Nine Months Ended | ||||||||||||||
30-Sep-14 | 30-Sep-13 | 30-Sep-14 | 30-Sep-13 | ||||||||||||||
Research and development | $ | 18,217 | $ | 183,168 | $ | 155,984 | $ | 158,575 | |||||||||
Selling, general and administrative | 15,892 | 1,355,175 | 134,846 | 1,465,590 | |||||||||||||
Total Stock based compensation | $ | 34,109 | $ | 1,538,343 | $ | 290,830 | $ | 1,624,165 | |||||||||
The Company granted -0- and 100,000 stock options, with a weighted-average grant date fair value of -0- and $2.81 per share, during the three and nine months ended September 30, 2014, respectively. The Company granted -0- and 35,000 stock options, with a weighted-average grant date fair value of $0.00 and $3.41 per share, during the three and nine months ended September 30, 2013, respectively. | |||||||||||||||||
During the nine months ended September 30, 2014, 67,391 stock options previously granted have vested and 37,142 stock options were forfeited. | |||||||||||||||||
As part of the Company’s non-employee Director compensation program and in connection with the Company’s annual meeting, on May 30, 2014 each continuing non-employee Director, Frederick Telling, Charles Pope, Alan Dunton, Christine Koski and Robert Koski was granted an award of 10,000 fully vested shares of the Company’s common stock under the Company’s 2012 Equity Incentive Plan. The grant date fair value of the 50,000 shares issued under the non-employee Director compensation program was determined to be $102,500. |
Warrants
Warrants | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Text Block [Abstract] | ' | ||||||||
Warrants | ' | ||||||||
5 | Warrants | ||||||||
A summary of warrant activity for the year ended December 31, 2013 and the nine months ended September 30, 2014 is as follows: | |||||||||
Warrants | Weighted | ||||||||
Average | |||||||||
Price | |||||||||
Balance – December 31, 2012 | 3,235,982 | $ | 3.53 | ||||||
Granted | — | — | |||||||
Exercised | (200,000 | ) | 1.5 | ||||||
Expired | (288,888 | ) | 19.87 | ||||||
Balance – December 31, 2013 | 2,747,094 | 1.91 | |||||||
Granted | — | — | |||||||
Exercised | (210,000 | ) | 1.5 | ||||||
Expired | (5,000 | ) | 10 | ||||||
Balance – September 30, 2014 | 2,532,094 | $ | 1.93 | ||||||
On January 13, 2014, we issued 135,000 shares of our common stock pursuant to a partial cashless exercise of 210,000 warrant shares relating to the warrants we issued to Griffin Securities, Inc. and its designees in connection with its service as placement agent in our July 2012 Private Financing. On April 15, 2014, warrants to acquire 5,000 shares of the Company’s common stock at a price of $10.00 per share expired. | |||||||||
The warrants outstanding as of September 30, 2014 are as follows: | |||||||||
Exercise Price | Warrants Outstanding | Expiration Dates | |||||||
$1.50 | 361,169 | 7/31/17 | |||||||
$2.00 | 2,170,925 | 3/23/15 | |||||||
2,532,094 | |||||||||
ShortTerm_Notes_Payable
Short-Term Notes Payable | 9 Months Ended | |
Sep. 30, 2014 | ||
Debt Disclosure [Abstract] | ' | |
Short-Term Notes Payable | ' | |
6 | Short-Term Notes Payable | |
As of September 30, 2014 and December 31, 2013, the Company had $109,564 and $64,051 respectively, in short-term notes payable for the financing of various insurance policies. On March 8, 2013, the Company entered into a short-term note payable for $50,037 bearing interest at 6.57% to finance the product liability insurance. Principal and interest payments on this note began April 10, 2013 and are made evenly based on a straight line amortization over a 10-month period with the final payment being made on January 10, 2014. On June 20, 2013, we entered into a short-term note payable for $106,994 bearing interest at 4.64% to finance a portion of the directors’ and officers’ liability insurance and employment practices liability insurance premiums. Principal and interest payments on this note began August 24, 2013 and are made evenly based on a straight line amortization over an 11-month period with the final payment due on June 24, 2014. On March 10, 2014, the Company entered into a short-term note payable for $50,694 bearing interest at 6.57% to finance the product liability insurance. Principal and interest payments on this note began April 10, 2014 and are made evenly based on a straight line amortization over a 10-month period with the final payment being made on January 10, 2015. On July 24, 2014, the Company entered into a short-term note payable for $108,306 bearing interest at 4.647% to finance a portion of the directors’ and officers’ liability insurance and employment practices liability insurance premiums. Principal and interest payments on this note began August 24, 2014 and are made evenly based on a straight line amortization over an 11-month period with the final payment being made on June 24, 2015. | ||
Commitments_and_Contingencies
Commitments and Contingencies | 9 Months Ended | |||
Sep. 30, 2014 | ||||
Commitments and Contingencies Disclosure [Abstract] | ' | |||
Commitments and Contingencies | ' | |||
7 | Commitments and Contingencies | |||
The University of Florida Research Foundation Licenses | ||||
UFRF-MU1140 and Replacement Therapy Licenses. In the Company’s UFRF amended license agreements for SMaRT Replacement Therapy and MU1140, the Company is obligated to pay 5% of the selling price of any products developed from the UFRF licensed technologies that the Company may sell as royalty to the UFRF. In addition, if the Company sublicenses any rights granted by the amended license agreements, the Company is obligated to pay to the UFRF 22% of all revenues received from the sublicenses, excluding monies received solely for development costs. The Company is also obligated to make the following payments to UFRF as follows: a one-time commercialization fee, post-commercialization minimum royalty payments, and a one-time cumulative royalty payment. The one-time commercialization fee would be due on the first anniversary of first commercial sale and is calculated at $5,000 per month between (1) May 1, 2013 (for the SMaRT Replacement Therapy license agreement) and April 1, 2013 (for the MU1140 license agreement) and (2) the month of the first anniversary of a commercial sale. No commercial sales have occurred and as such no commercialization fess have been paid. The post-commercialization minimum royalty payments of $50,000 annually would be due following payment of a commercialization fee. The one-time additional royalty payment would be due when total cumulative royalties paid to UFRF exceed $2.0 million, upon which we would be obligated to make a one-time additional payment to UFRF of 10% of the total royalties due to UFRF in the calendar year in which cumulative royalties exceeded $2.0 million. | ||||
The Company is required to make minimum annual maintenance payments to the UFRF for the term of the amended license agreements in the amount of $10,000 for each license agreement and $20,000 in aggregate. The aggregate minimum annual payments are required to be paid in advance on a quarterly basis (i.e. $5,000 per quarter for both licenses). The Company must also pay all patent costs and expenses incurred by the UFRF for the preparation, filing, prosecution, issuance and maintenance of the patents. | ||||
The terms of the UFRF amended license agreements expire upon the earlier of (i) the date that no patents covered by the amended license agreements remain enforceable or (ii) the payment of earned royalties under the amended license agreements, once begun, ceases for more than three calendar quarters. The Company may voluntarily terminate the license agreement upon 90 days written notice to UFRF. UFRF may terminate the amended license agreements if the Company breaches its obligations to timely pay any amounts due under the amended license agreements, to submit development reports as required under the amended license agreements or commit any other breach of any other covenants contained in the amended license agreements and the Company fails to remedy such breach within 90 days after written notice of such breach by UFRF. | ||||
After the effective date of termination of the SMaRT Replacement Therapy amended license agreement, the Company may sell all licensed products and complete licensed products in the process of manufacture at the time of such termination and sell the same, provided the Company makes the royalty payments described above and submit the reports required under the SMaRT Replacement Therapy amended license agreement. | ||||
Texas A&M License Agreement | ||||
Under the terms of the Texas A&M license agreement, the Company made an initial payment of five thousand dollars ($5,000) to Texas A&M. The Company must also pay to Texas A&M a royalty of five percent (5%) of net sales of products that include the licensed technology, subject to royalty stacking provisions with a two percent (2%) minimum royalty. Additionally, in order to maintain the exclusive license, commencing in 2014 and each year thereafter prior to the calendar year of the first sale of products using the licensed technology, the Company must pay Texas A&M $15,000 as minimum consideration for the continuation of the license agreement. Once the Company commences the sale of products that include the technology the Company licenses from Texas A&M the Company must pay a minimum annual amount of $100,000 to Texas A&M and every year thereafter through the expiration of the Agreement. However, once sales begin, any royalty payments the Company makes on net sales will be credited against the $100,000 required maintenance payment. | ||||
The Company must also pay all patent costs and expenses for the preparation, filing, prosecution, issuance and maintenance of the patent rights. Sales by sublicensees are subject to the royalty rate above, and the Company is responsible for certain payments to Texas A&M for any other consideration received that is not in the form of a royalty. | ||||
Pursuant to the Texas A&M license agreement, the Company shall use commercially reasonable efforts to achieve the following milestones to the satisfaction of Texas A&M and make milestone payments: (i) enrollment of first patient in a Phase I clinical trial using the licensed technology, to occur on or before June 1, 2015, with a milestone achievement payment of $50,000, (ii) completion of Phase II clinical trial using the licensed technology to occur on or before June 1, 2019, with a milestone achievement payment of $100,000, (iii) completion of Phase III clinical trial of the licensed technology to occur on or before June 1, 2022, with a milestone achievement payment of $150,000, and (iv) first sale of the licensed technology to occur on or before June 1, 2025 with a milestone achievement payment of $400,000. If we fail to accomplish the milestones or fail to achieve net sales of products including the licensed technology for two consecutive calendar years Texas A&M at its sole option may waive the requirement, renegotiate the missed milestones or terminate the license agreement. None of the Texas A&M milestones had been achieved as of September 30, 2014. | ||||
The term of the Texas A&M license agreement expires upon (i) the expiration of the applicable patent rights covered by the license agreement, (ii) the failure of any patent filed pursuant to the license agreement to issue, or (iii) the final and unappealable determination by a court that the patent rights are invalid. The Company may voluntarily terminate the license agreement upon 90 days written notice to Texas A&M. Texas A&M can terminate the license agreement if the Company materially breaches the license agreement and does not cure such breach within 60 days of receiving notice of such breach from Texas A&M. | ||||
The Lantibiotic Exclusive Channel Collaboration (“ECC”) | ||||
Under the Lantibiotic ECC, and subject to certain exceptions, the Company is responsible for, among other things, funding the further anticipated development of lantibiotics toward the goal of commercialization, conducting preclinical and clinical development of candidate lantibiotics, as well as for other aspects of manufacturing and the commercialization of the product(s). Among other things, Intrexon is responsible for technology discovery efforts, cell-engineering development, certain aspects of the manufacturing process, and costs of filing, prosecution and maintenance of Intrexon’s patents. | ||||
Subject to certain expense allocations and other offsets provided in the Lantibiotic ECC, the Company will pay Intrexon on a quarterly basis 25% of gross quarterly profits derived in that quarter from the sale of products developed from the Lantibiotic ECC, calculated on an Oragenics Product-by-Oragenics Product basis. The Company has likewise agreed to pay Intrexon on a quarterly basis 50% of revenue obtained in that quarter from a sublicensor in the event of a sublicensing arrangement. | ||||
In addition, in partial consideration for each party’s execution and delivery of the Lantibiotic ECC, the Company entered into a Stock Issuance Agreement with Intrexon. Pursuant to the Stock Issuance Agreement, the Company issued to Intrexon 4,392,425 shares of the Company’s common stock as an initial technology access fee, in consideration for the execution and delivery of the Lantibiotic ECC and granted Intrexon certain equity participation rights and registration rights. Under the Stock Issuance Agreement and as part of the Lantibiotic ECC, the Company has also agreed to make certain payments to Intrexon upon the Company’s achievement of designated milestones in the form of shares of Company common stock or, at the Company’s option, make a cash payment to Intrexon (based upon the fair market value of the shares otherwise required to be issued). The milestone events and amounts payable are as follows: | ||||
(i) | upon filing of the first Investigational New Drug application with the U.S. Food and Drug Administration for an Oragenics Product, that number of shares equal to the number of shares of common stock comprising 1.0% of the Base Shares (as defined below); | |||
(ii) | upon the dosing of the first patient in the first Phase 2 clinical study with an Oragenics Product, that number of shares equal to the number of shares of common stock comprising 1.5% of the Base Shares; | |||
(iii) | upon the dosing of the first patient in the first Phase 3 clinical study with an Oragenics Product, that number of shares equal to the number of shares of common stock comprising 2% of the Base Shares; | |||
(iv) | upon the filing of the first New Drug Application (“NDA”) or Biologics License Application (“BLA”) with the U.S. Food and Drug Administration for an Oragenics Product, or alternatively the filing of the first equivalent regulatory filing with a foreign regulatory agency, that number of shares equal to the number of shares of Common Stock comprising 2.5% of the Base Shares; and | |||
(v) | upon the granting of the first regulatory approval of an Oragenics Product, that number of shares equal to the number of shares of Common Stock comprising 3% of the Base Shares. | |||
Base Shares is defined in the Stock Issuance Agreement to mean (i) the number of shares of Company common stock together with any securities or instruments convertible or exercisable for shares of common stock issued and outstanding at the time of the applicable milestone event, (ii) minus any shares issuable upon conversion of Capital Inducement Securities. Capital Inducement Securities is defined in the Stock Issuance Agreement to mean warrants or other convertible securities of the Company issued to investors in connection with a debt or equity investment in the Company that are issued in addition to the primary investment securities and in an amount not to exceed 10% of the overall number of shares issued in the investment (on an as-converted to common stock basis) | ||||
None of the Lantibiotic ECC milestones had been achieved as of September 30, 2014. | ||||
Intrexon may terminate the Lantibiotic ECC if we fail to use diligent efforts to develop and commercialize Oragenics Products or if we elect not to pursue the development of a Lantibiotics Program identified by Intrexon that is a “Superior Therapy” as defined in the Lantibiotic ECC. We may voluntarily terminate the Lantibiotic ECC at any time upon 90 days written notice to Intrexon. | ||||
Upon termination of the Lantibiotic ECC, the Company may continue to develop and commercialize any Oragenics Product that has been, at the time of termination: | ||||
• | commercialized by the Company; | |||
• | approved by regulatory authorities; | |||
• | a subject of an application for regulatory approval that is pending before the applicable regulatory authority; or | |||
• | the subject of at least an ongoing Phase 1, Phase 2 or Phase 3 clinical trial in the Field (in the case of a termination by Intrexon due to an uncured material breach by the Company or a voluntary termination by the Company). | |||
The Company’s obligation to pay 25% of gross profits or revenue and milestone payments described above with respect to these “retained” products as well as to use diligent efforts to develop and commercialize these “retained” Oragenics Products will survive termination of the Lantibiotic ECC. | ||||
The Probiotic ECC | ||||
Under the Probiotic ECC, and subject to certain exceptions, the Company is responsible for, among other things, funding the further anticipated development of probiotics toward the goal of commercialization, conducting preclinical and clinical development of candidate probiotics, as well as for other aspects of manufacturing and the commercialization of the product(s). Among other things, Intrexon is responsible for technology discovery efforts, cell-engineering development, certain aspects of the manufacturing process, and costs of filing, prosecution and maintenance of Intrexon’s patents. | ||||
The Company will pay Intrexon 10% of the net sales derived from the sale of products developed from the exclusive channel collaboration relating to the Probiotics Program. The Company has likewise agreed to pay Intrexon a percentage of revenue obtained from a sublicensee in the event of a sublicensing arrangement. The percentage of the revenue to be paid will be determined at the time that a sublicense agreement is negotiated. | ||||
Under the SPIA and as part of the Probiotic ECC, the Company has also agreed to make certain payments to Intrexon upon the Company’s achievement of designated milestones. The milestone payments are each payable to Intrexon, at the Company’s election (subject to an election right of Intrexon if the milestone is achieved by a sublicensee), either in cash or in shares of Company common stock (using the fair market value of the shares to calculate the number of shares to be issued to Intrexon in lieu of cash). The Commercialization Milestone Events and amounts payable are as follows: | ||||
• | $2,000,000 within thirty (30) days of the dosing of a patient by or on behalf of the Company, or an Affiliate (as that term is defined in the Probiotic ECC) or permitted sublicensee of the Company, in a phase II clinical trial, whether such occurs in the United States of America under the jurisdiction of the United States Food and Drug Administration (“FDA”) or elsewhere under the jurisdiction of a foreign regulatory agency, for a Company Product; | |||
• | $5,000,000 within thirty (30) days of the first meeting of the primary endpoint by or on behalf of the Company, or an Affiliate or permitted sublicensee of the Company, in a phase III clinical trial, whether such occurs in the United States of America under the jurisdiction of the FDA or elsewhere under the jurisdiction of a foreign regulatory agency, for a Company Product; | |||
• | $10,000,000 within thirty (30) days of the first to occur of (a) the First Commercial Sale (as that term is defined in the Probiotic ECC) of a Company Product, or (b) the approval of a New Drug Application (as that term is defined in the Probiotic ECC) for a Company Product by the FDA or equivalent regulatory action in a foreign jurisdiction. | |||
None of the Probiotic ECC milestones had been achieved as of September 30, 2014. | ||||
The Company may voluntarily terminate the Probiotic ECC upon 90 days written notice to Intrexon. Intrexon may also terminate the Probiotic ECC if the Company breaches the Probiotic ECC and fails to cure the breach within 60 days or the Company does not pursue development of the Superior Therapy under the probiotics identified by Intrexon that is a “Superior Therapy” as defined in the Probiotic ECC. Upon termination of the Probiotic ECC, the Company may continue to develop and commercialize any Company Product that, at the time of termination, satisfies at least one of the following criteria: | ||||
• | commercialized by the Company; | |||
• | approved by regulatory authorities; | |||
• | a subject of an application for regulatory approval that is pending before the applicable regulatory authority; or | |||
• | the subject of at least an ongoing Phase 1, Phase 2 or Phase 3 clinical trial in the field of the Probiotics Program. | |||
The Company’s obligation to pay 10% of net sales and the milestone payments described above with respect to these “retained” products as well as to use diligent efforts to develop and commercialize these “retained” Company Products will survive termination of the Probiotic ECC. |
Related_Party_Transactions
Related Party Transactions | 9 Months Ended | |
Sep. 30, 2014 | ||
Related Party Transactions [Abstract] | ' | |
Related Party Transactions | ' | |
8 | Related Party Transactions | |
During the three and nine months ended September 30, 2014 and 2013, we paid $8,093 and $909,411; and $474,837 and $1,245,535, respectively, to Intrexon Corporation (Intrexon) under the Exclusive Channel Collaboration Agreements (ECC Agreements) (See Note 7). Included in accounts payable and accrued expenses at September 30, 2014 and 2013 was $2,535 and $81,073, respectively, related to unpaid invoices received from Intrexon relating to work performed under the ECC Agreements. As of September 30, 2014 and 2013 Intrexon owned approximately 24% and 23%, respectively, of our outstanding common stock. |
Common_Stock
Common Stock | 9 Months Ended | |
Sep. 30, 2014 | ||
Equity [Abstract] | ' | |
Common Stock | ' | |
9 | Common Stock | |
On May 30, 2014 the Company held its Annual meeting of Shareholders, at which, the Company’s shareholders authorized the amendment to our Amended and Restated Articles of Incorporation to increase the number of authorized shares of common stock from 50,000,000 shares to 100,000,000 shares, upon a determination by our Board of Directors that such an increase is in the best interests of our Company and our shareholders. | ||
As part of the Company’s non-employee Director compensation program and in connection with the Company’s annual meeting, on May 30, 2014 each continuing non-employee Director, Frederick Telling, Charles Pope, Alan Dunton, Christine Koski and Robert Koski was granted an award of 10,000 fully vested shares of the Company’s common stock under the Company’s 2012 Equity Incentive Plan. |
Significant_Accounting_Policie1
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2014 | |
Recently Issued Accounting Pronouncements | ' |
Recently Issued Accounting Pronouncements | |
In August 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40) Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern.” ASU 2014-15 provides guidance on management’s responsibility in evaluating whether there is substantial doubt about a company’s ability to continue as a going concern and about related footnote disclosures. For each reporting period, management will be required to evaluate whether there are conditions or events that raise substantial doubt about a company’s ability to continue as a going concern within one year from the date the financial statements are issued. Management will also be required to evaluate and disclose whether its plans alleviate that doubt. ASU 2014 – 15 is effective for the annual period ending after December 15, 2016, and for interim periods within annual periods ending after December 15, 2016. Earlier application is permitted. The Company is currently evaluating the requirements of ASU 2014-15 and has not yet determined its impact on the Company’s financial statements. | |
In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2014-09, “Revenue from Contracts with Customers (Topic 606).” ASU 2014-09 completes the joint effort by the FASB and International Accounting Standards Board (IASB) to improve financial reporting by creating common revenue recognition guidance for U.S. GAAP and International Financial Reporting Standards (IFRS). ASU 2014-09 applies to all companies that enter into contracts with customers to transfer goods or services. ASU 2014-09 is effective for public entities for interim and annual reporting periods beginning after December 15, 2016. Early application is not permitted and entities have the choice to apply ASU 2014-09 either retrospectively to each reporting period presented or by recognizing the cumulative effect of applying ASU 2014-09 at the date of initial application and not adjusting comparative information. The Company is currently evaluating the requirements of ASU 2014-09 and has not yet determined its impact on the Company’s financial statements. | |
In July 2013, the FASB issued new accounting guidance on the presentation of unrecognized tax benefits, Accounting Standards Update No. 2013-11, “Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists,” for fiscal years, and interim periods within those years, beginning after December 15, 2013 The new guidance requires an entity to present an unrecognized tax benefit, or a portion of an unrecognized tax benefit, as a reduction to a deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward, except as follows: to the extent a net operating loss carryforward, a similar tax loss, or a tax credit carryforward is not available at the reporting date under the tax law of the applicable jurisdiction to settle any additional income taxes that would result from the disallowance of a tax position or the tax law of the applicable jurisdiction does not require the entity to use, and the entity does not intend to use the deferred tax asset for such purpose, then the unrecognized tax benefit should be presented in the financial statements as a liability and should not be combined with deferred tax assets. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2013, with early adoption permitted. Accordingly, we adopted these presentation requirements during the first quarter of 2014. The adoption of this new guidance did not have a material impact on our financial statements or related disclosures. | |
There are no other new accounting pronouncements issued or effective during the third quarter of 2014 that have had or are expected to have an impact on the Company’s financial statements. | |
Use of Estimates | ' |
Use of Estimates | |
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. The principal areas of estimation reflected in the financial statements are anticipated milestone payments, stock based compensation, valuation of warrants, income tax valuation allowance, inventory obsolescence reserve, sales returns and allowances and the allowance for doubtful accounts. | |
Guaranteed Rights of Return | ' |
Guaranteed Rights of Return | |
The Company has granted guaranteed rights of return to two dental distributors. The Company defers recognition of revenue on these accounts until either the distributor provides notification to the Company that the product has been sold to the end consumer or the guaranteed right of return period expires. Once notification has been received and verified, the Company records revenue in that accounting period. The Company had $25,592 and $18,839 of revenue deferred under guaranteed rights of return arrangements included in deferred revenue in the balance sheets as of September 30, 2014 and December 31, 2013, respectively. | |
Inventory | ' |
Inventory | |
Inventory is stated at the lower of cost or market. Cost, which includes material, labor and overhead, is determined on a first-in, first-out basis. On a quarterly basis, we analyze our inventory levels and reserve for inventory that is expected to expire prior to being sold, inventory that has a cost basis in excess of its expected net realizable value, inventory in excess of expected sales requirements, or inventory that fails to meet commercial sale specifications. Expired inventory is disposed of and the related costs are written off to the reserve for inventory obsolescence. The inventory reserve was approximately $41,200 and $31,500 as of September 30, 2014 and December 31, 2013, respectively. | |
Stock-Based Payment Arrangements | ' |
Stock-Based Payment Arrangements | |
Generally, all forms of stock-based payments, including stock option grants, warrants, and restricted stock grants are measured at their fair value on the awards’ grant date typically using a Black-Scholes pricing model. Stock-based compensation awards issued to non-employees for services rendered are recorded at the fair value of the stock-based payment. The expense resulting from stock-based payments are recorded in research and development expense or selling, general and administrative expense in the statement of operations, depending on the nature of the services provided. Stock-based payment expense is recorded over the requisite service period in which the grantee provides services to us, to the extent the stock option grants, warrants, or restricted stock grants do not vest at the grant date they are subject to forfeiture. | |
Stock-Based Compensation | ' |
Stock-Based Compensation | |
GAAP requires all share-based payments to employees, including grants of employee stock options, to be recognized in the financial statements based on their fair values as of the grant date. Stock-based compensation expense is recorded over the requisite service period in which the grantee provides services to us, to the extent the options do not vest at the grant date and are subject to forfeiture. For performance-based awards that do not include market-based conditions, we record share-based compensation expense only when the performance-based milestone is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether milestones are probable of achievement. | |
For awards with market-based performance conditions, we recognize the grant-date fair value of the award over the derived service period regardless of whether the underlying performance condition is met. | |
Net Loss Per Share | ' |
Net Loss Per Share | |
During all periods presented, the Company had securities outstanding that could potentially dilute basic earnings per share in the future, but were excluded from the computation of diluted net loss per share, as their effect would have been antidilutive. Because the Company reported a net loss for all periods presented, shares associated with the stock options and warrants are not included because they are antidilutive. Basic and diluted net loss per share amounts are the same for the periods presented. Net loss per share is computed using the weighted average number of shares of common stock outstanding. | |
Revenue Recognition | ' |
Revenue Recognition | |
The Company recognizes revenues from the sales of product when title and risk of loss pass to the customer, which is generally when the product is shipped. Grant revenues are recognized as the reimbursable expenses are incurred over the life of the related grant. Grant revenues are deferred when reimbursable expenses have not been incurred. | |
The Company records allowances for discounts and product returns at the time of sale as a reduction of revenues as such allowances can be reliably estimated based on historical experience or known trends. The Company maintains a return policy that allows customers to return product within a specified period of time prior to and subsequent to the expiration date of the product. The estimate of the provision for returns is analyzed quarterly and is based upon many factors, including industry data of product return rates, historical experience of actual returns, analysis of the level of inventory in the distribution channel, if any, and reorder rates. If the history or product returns changes, the reserve will be adjusted. While the Company believes that the reserves it has established are reasonable and appropriate based upon current facts and circumstances, applying different judgments to the same facts and circumstances would result in the estimated amounts for sales returns and chargebacks to vary. Because the ProBiora3 products have only had limited distribution, the Company could experience different circumstances in the future and these differences could be material. | |
Concentrations | ' |
Concentrations | |
The Company is dependent on key suppliers to provide probiotics, blending, warehousing and packaging of its EvoraPlus, EvoraKids, EvoraPro, and Teddy’s Pride products. The Company had four key suppliers during the three and nine months ended September 30, 2014 and 2013. The majority of the Company’s cost of sales are from these key suppliers during the three and nine months ended September 30, 2014 and 2013. Accounts payable and accrued expenses for these vendors totaled approximately $90,504 and $146,284 as of September 30, 2014 and December 31, 2013, respectively. | |
Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains cash accounts in commercial banks, which may, at times, exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk on cash and cash equivalents. As of September 30, 2014, the uninsured portion of this balance was $11,514,923. As of December 31, 2013, the uninsured portion of this balance was $16,026,510. | |
Warrant [Member] | ' |
Warrants | ' |
Warrants | |
The Company used the Black Scholes Option Pricing Model in calculating the relative fair value of any warrants that are issued. |
Stockbased_Compensation_Tables
Stock-based Compensation (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | ||||||||||||||||
Stock-based Compensation Expense Recognized | ' | ||||||||||||||||
The Company recognized stock-based compensation on all employee and non-employee awards as follows: | |||||||||||||||||
Three Months Ended | Three Months Ended | Nine Months Ended | Nine Months Ended | ||||||||||||||
30-Sep-14 | 30-Sep-13 | 30-Sep-14 | 30-Sep-13 | ||||||||||||||
Research and development | $ | 18,217 | $ | 183,168 | $ | 155,984 | $ | 158,575 | |||||||||
Selling, general and administrative | 15,892 | 1,355,175 | 134,846 | 1,465,590 | |||||||||||||
Total Stock based compensation | $ | 34,109 | $ | 1,538,343 | $ | 290,830 | $ | 1,624,165 | |||||||||
Warrants_Tables
Warrants (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Text Block [Abstract] | ' | ||||||||
Summary of Warrant Activity | ' | ||||||||
A summary of warrant activity for the year ended December 31, 2013 and the nine months ended September 30, 2014 is as follows: | |||||||||
Warrants | Weighted | ||||||||
Average | |||||||||
Price | |||||||||
Balance – December 31, 2012 | 3,235,982 | $ | 3.53 | ||||||
Granted | — | — | |||||||
Exercised | (200,000 | ) | 1.5 | ||||||
Expired | (288,888 | ) | 19.87 | ||||||
Balance – December 31, 2013 | 2,747,094 | 1.91 | |||||||
Granted | — | — | |||||||
Exercised | (210,000 | ) | 1.5 | ||||||
Expired | (5,000 | ) | 10 | ||||||
Balance – September 30, 2014 | 2,532,094 | $ | 1.93 | ||||||
Summary of Warrants Outstanding | ' | ||||||||
The warrants outstanding as of September 30, 2014 are as follows: | |||||||||
Exercise Price | Warrants Outstanding | Expiration Dates | |||||||
$1.50 | 361,169 | 7/31/17 | |||||||
$2.00 | 2,170,925 | 3/23/15 | |||||||
2,532,094 | |||||||||
Basis_of_Presentation_Addition
Basis of Presentation - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | Dec. 31, 2012 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ' | ' | ' | ' | ' | ' |
Revenues generated by company | $201,010 | $253,374 | $719,422 | $597,449 | ' | ' |
Net loss | -1,029,544 | -9,325,424 | -4,565,947 | -12,989,419 | ' | ' |
Cash used in operations | ' | ' | -4,378,396 | -5,545,205 | ' | ' |
Accumulated deficit | 74,721,063 | ' | 74,721,063 | ' | 70,155,116 | ' |
Gross proceeds from issuance of common stock through private placement | ' | ' | ' | $3,939,800 | $14,900,000 | $13,000,000 |
Significant_Accounting_Policie2
Significant Accounting Policies - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | |
Supplier | Supplier | Supplier | Supplier | ||
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' |
Number of dental distributor with guaranteed rights of returns | ' | ' | 2 | ' | ' |
Revenue deferred under guaranteed rights of return arrangements | $25,592 | ' | $25,592 | ' | $18,839 |
Inventory reserve | 41,200 | ' | 41,200 | ' | 31,500 |
Accounts payable and accrued expenses for key suppliers | 604,351 | ' | 604,351 | ' | 909,957 |
Uninsured portion of cash balance | 11,514,923 | ' | 11,514,923 | ' | 16,026,510 |
Supplier Concentration Risk [Member] | ' | ' | ' | ' | ' |
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' |
Number of key suppliers | 4 | 4 | 4 | 4 | ' |
Accounts payable and accrued expenses for key suppliers | 90,504 | ' | 90,504 | ' | 146,284 |
Guaranteed Rights of Return [Member] | ' | ' | ' | ' | ' |
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' |
Revenue deferred under guaranteed rights of return arrangements | $25,592 | ' | $25,592 | ' | $18,839 |
Stockbased_Compensation_Stockb
Stock-based Compensation - Stock-based Compensation Expense Recognized (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Total Stock based compensation | $34,109 | $1,538,343 | $290,830 | $1,624,165 |
Research and Development Expense [Member] | ' | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Total Stock based compensation | 18,217 | 183,168 | 155,984 | 158,575 |
Selling, General and Administrative Expenses [Member] | ' | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Total Stock based compensation | $15,892 | $1,355,175 | $134,846 | $1,465,590 |
Stockbased_Compensation_Additi
Stock-based Compensation - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | 0 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | 30-May-14 | |
Non- employee Directors [Member] | |||||
2012 Equity Incentive Plan [Member] | |||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' | ' |
Stock options granted | 0 | 0 | 100,000 | 35,000 | ' |
Weighted-average grant date fair value | $0 | $0 | $2.81 | $3.41 | ' |
Stock options vested | ' | ' | 67,391 | ' | ' |
Stock options forfeited | ' | ' | 37,142 | ' | ' |
Number of fully vested shares granted as award | ' | ' | ' | ' | 10,000 |
Shares issued under incentive plan | ' | ' | ' | ' | 50,000 |
Grant date fair value of shares issued | ' | ' | ' | ' | $102,500 |
Warrants_Summary_of_Warrant_Ac
Warrants - Summary of Warrant Activity (Detail) (USD $) | 0 Months Ended | 9 Months Ended | 12 Months Ended |
Apr. 15, 2014 | Sep. 30, 2014 | Dec. 31, 2013 | |
Equity [Abstract] | ' | ' | ' |
Warrants, Beginning balance | ' | 2,747,094 | 3,235,982 |
Warrants, Granted | ' | 0 | 0 |
Warrants, Exercised | ' | -210,000 | -200,000 |
Warrants, Expired | -5,000 | -5,000 | -288,888 |
Warrants, Ending balance | ' | 2,532,094 | 2,747,094 |
Weighted Average Price, Beginning balance | ' | $1.91 | $3.53 |
Weighted Average Price, Granted | ' | $0 | $0 |
Weighted Average Price, Exercised | ' | $1.50 | $1.50 |
Weighted Average Price, Expired | $10 | $10 | $19.87 |
Weighted Average Price, Ending balance | ' | $1.93 | $1.91 |
Warrants_Additional_Informatio
Warrants - Additional Information (Detail) (USD $) | 0 Months Ended | 9 Months Ended | 12 Months Ended | 0 Months Ended |
Apr. 15, 2014 | Sep. 30, 2014 | Dec. 31, 2013 | Jan. 13, 2014 | |
Adrian Stecyk [Member] | ||||
Class of Warrant or Right [Line Items] | ' | ' | ' | ' |
Warrants exercised | ' | 210,000 | 200,000 | 210,000 |
Shares of common stock issued upon exercise of warrants | ' | ' | ' | 135,000 |
Shares underlying warrant outstanding | 5,000 | 5,000 | 288,888 | ' |
Warrants exercisable price per share | $10 | $10 | $19.87 | ' |
Warrants_Summary_of_Warrants_O
Warrants - Summary of Warrants Outstanding (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Sep. 30, 2014 | Sep. 30, 2014 |
Range 1 [Member] | Range 2 [Member] | ||||
Class of Warrant or Right [Line Items] | ' | ' | ' | ' | ' |
Exercise Price | ' | ' | ' | $1.50 | $2 |
Warrants Outstanding | 2,532,094 | 2,747,094 | 3,235,982 | 361,169 | 2,170,925 |
Expiration Dates | ' | ' | ' | 31-Jul-17 | 23-Mar-15 |
ShortTerm_Notes_Payable_Additi
Short-Term Notes Payable - Additional Information (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 |
Product Liability Insurance Financings One [Member] | Product Liability Insurance Financings Two [Member] | Directors and Officers Liability Insurance Financings One [Member] | Directors and Officers Liability Insurance Financings Two [Member] | |||
Short Term Note Payable [Member] | Short Term Note Payable [Member] | Short Term Note Payable [Member] | Short Term Note Payable [Member] | |||
Short-term Debt [Line Items] | ' | ' | ' | ' | ' | ' |
Short term notes payable for financing insurance policies | $109,564 | $64,051 | ' | ' | ' | ' |
Short-term note payable | ' | ' | $50,037 | $50,694 | $106,994 | $108,306 |
Interest rate on short-term note | ' | ' | 6.57% | 6.57% | 4.64% | 4.65% |
Debt instrument issuance date | ' | ' | 8-Mar-13 | 10-Mar-14 | 20-Jun-13 | 24-Jul-14 |
Short-term notes payable amortization period | ' | ' | '10 months | '10 months | '11 months | '11 months |
Final payment date of short-term note payable | ' | ' | 10-Jan-14 | 10-Jan-15 | 24-Jun-14 | 24-Jun-15 |
Commitments_and_Contingencies_
Commitments and Contingencies - Additional Information (Detail) (USD $) | 9 Months Ended |
Sep. 30, 2014 | |
UFRF License Agreements [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Company's obligation to pay from percentage of selling price of product | 5.00% |
Company's obligation to pay from all revenue received from sublicenses | 22.00% |
One-time commercialization fee monthly amount for calculation | $5,000 |
Post-commercialization minimum royalty payments | 50,000 |
One-time additional royalty payment would be due when total cumulative royalties paid to UFRF exceed amount | 2,000,000 |
One-time additional payment to UFRF as a percentage of total royalties due to UFRF | 10.00% |
Commercial sales | 0 |
Commercialization fees | 0 |
Minimum annual maintenance payment per license agreement | 10,000 |
Aggregate minimum annual maintenance payment | 20,000 |
Quarterly maintenance payment to UFRF under installment plan | 5,000 |
Termination notice period | '90 days |
Texas A and M University License [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Company's obligation to pay from percentage of selling price of product | 5.00% |
Post-commercialization minimum royalty payments | 100,000 |
Initial payment to Texas A&M | 5,000 |
Minimum consideration for the continuation of the license agreement | 15,000 |
Annual maintenance payment under licensing agreement with Texas A&M | 100,000 |
Maximum period to cure the breach | '60 days |
Termination notice period | '90 days |
Texas A and M University License [Member] | Phase I Clinical Trial [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Date of milestone achievement under licensing agreement with Texas A&M | 1-Jun-15 |
Milestone payment under licensing agreement | 50,000 |
Texas A and M University License [Member] | Phase II Clinical Trial [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Date of milestone achievement under licensing agreement with Texas A&M | 1-Jun-19 |
Milestone payment under licensing agreement | 100,000 |
Texas A and M University License [Member] | Phase III Clinical Trial [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Date of milestone achievement under licensing agreement with Texas A&M | 1-Jun-22 |
Milestone payment under licensing agreement | 150,000 |
Texas A and M University License [Member] | Sale Of Licensed Technology [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Date of milestone achievement under licensing agreement with Texas A&M | 1-Jun-25 |
Milestone payment under licensing agreement | 400,000 |
Texas A and M University License [Member] | Minimum [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Company's obligation to pay from percentage of selling price of product | 2.00% |
Probiotics ECC [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Company's obligation to pay from percentage of selling price of product | 10.00% |
Maximum period to cure the breach | '60 days |
Number of milestones achieved | 0 |
Termination notice period | '90 days |
Milestone measurement period | '30 days |
Probiotics ECC [Member] | Phase II Clinical Trial [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Milestone payment under licensing agreement | 2,000,000 |
Probiotics ECC [Member] | Phase III Clinical Trial [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Milestone payment under licensing agreement | 5,000,000 |
Probiotics ECC [Member] | Sale Of Licensed Technology [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Milestone payment under licensing agreement | $10,000,000 |
Lantibiotic Exclusive Channel Collaboration (ECC) [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Company's obligation to pay from percentage of selling price of product | 25.00% |
Company's obligation to pay from all revenue received from sublicenses | 50.00% |
Number of shares issued | 4,392,425 |
Maximum percentage of primary investment securities to investment of shares issued | 10.00% |
Number of milestones achieved | 0 |
Termination notice period | '90 days |
Lantibiotic Exclusive Channel Collaboration (ECC) [Member] | Investigational New Drug Application [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Percentage of number of shares of common stock equal to Base Shares | 1.00% |
Lantibiotic Exclusive Channel Collaboration (ECC) [Member] | Clinical Study Phase 2 [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Percentage of number of shares of common stock equal to Base Shares | 1.50% |
Lantibiotic Exclusive Channel Collaboration (ECC) [Member] | Clinical Study Phase 3 [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Percentage of number of shares of common stock equal to Base Shares | 2.00% |
Lantibiotic Exclusive Channel Collaboration (ECC) [Member] | Filing of First Investigational New Drug Application [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Percentage of number of shares of common stock equal to Base Shares | 2.50% |
Lantibiotic Exclusive Channel Collaboration (ECC) [Member] | First Regulatory Approval of Oragenics Product [Member] | ' |
Commitment And Contingencies [Line Items] | ' |
Percentage of number of shares of common stock equal to Base Shares | 3.00% |
Related_Party_Transactions_Add
Related Party Transactions - Additional Information (Detail) (Principal Owner [Member], Lantibiotic Exclusive Channel Collaboration (ECC) [Member], USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Related Party Transaction [Line Items] | ' | ' | ' | ' |
Cash paid to intrexon corporation | $8,093 | $474,837 | $909,411 | $1,245,535 |
Accounts payable and accrued expenses | $2,535 | $81,073 | $2,535 | $81,073 |
Intrexon [Member] | ' | ' | ' | ' |
Related Party Transaction [Line Items] | ' | ' | ' | ' |
Percentage of outstanding common stock | ' | ' | 24.00% | 23.00% |
Common_Stock_Additional_Inform
Common Stock - Additional Information (Detail) | Sep. 30, 2014 | 30-May-14 | Dec. 31, 2013 | 30-May-14 |
Non- employee Directors [Member] | ||||
2012 Equity Incentive Plan [Member] | ||||
Class of Stock [Line Items] | ' | ' | ' | ' |
Common stock, shares authorized | 100,000,000 | 100,000,000 | 50,000,000 | ' |
Number of fully vested shares granted as award | ' | ' | ' | 10,000 |